Menopause study weighs efficacy of supplements

May 05, 2002|By Patty Shillington, Knight Ridder Newspapers.

MIAMI — One of the principal problems with dietary supplements, at least from the American medical establishment's point of view, is the lack of scientific evidence to back up the manufacturers' claims.

So University of Miami researchers are excited to be taking on a rigorous clinical trial testing the safety and effectiveness of an herbal pill designed to treat the symptoms of menopause.

The trial will be double-blind and randomized--in other words, some of the 250 women will receive a placebo and others will receive the supplement. But neither the women nor the researchers will know who is getting what.

"It's the purest scientific study; it ferrets out bias," said Dr. Wayne Whitted, an assistant professor of gynecology who also has a private practice devoted to treating women in menopause. Whitted is the co-principal investigator for the four-month study, which was scheduled to begin last month.

Whitted and Arlette Perry, a clinical physiologist and the study's principal investigator, said studies like this one are past due.

"I think many, if not most, women have tried some sort of alternative product," Whitted said. "But they really have not been studied in a scientific way that shows whether the product can assist women."

Sales of herbal potions and supplements marketed to menopausal women are rising exponentially. In 1999, grocery and drug store sales of soy isoflavones, a phytoestrogen, rose to $21 million, more than triple the 1998 figures. And sales for general menopausal formulas were $36.2 million in '99, up by nearly 200 percent, according to the market research firms Spins and ACNielsen.

The supplement maker funding the study cannot be named because it could compromise the blind nature of the research, Perry said. One of the two products the study will address already is on the market, she said. The unidentified pill's primary ingredients are black cohosh, kava kava and isoflavones.

"Some of the ingredients have been investigated independently and have been shown to be effective," Perry said. "However, the combination of ingredients has not been looked at together and that's the beauty of it."

Perry said she had to persuade herself to take on the study when the "nutriceutical" company came calling.

"I'm a scientist, so I'm a skeptic about these natural remedies," she said. "I did a lot of digging to see if I even wanted to do a study like this.

"We have good evidence to suggest it will be effective, and that's why the company is willing to put forward money to find out for sure."

In addition, Perry said "the ingredients are in the amounts that have been shown to be safe."